Launch of global summit to preserve antimicrobials
Authors: Rebecca Barksby
Journal: The Lancet Microbe (2023)

On May 4–5, 2023, more than 200 representatives from drug regulatory bodies and health agencies met for the 1st Global Joint Summit of Human and Veterinary Medicines Regulatory Authorities to Preserve Antimicrobials (Geneva, Switzerland). The Summit was led by the Quadripartite for antimicrobial resistance (AMR)—a four-institution working group comprising of the Food and Agriculture Organization, UN Environmental Programme, World Organisation for Animal Health, and WHO—and marked the beginning of a global effort to maintain the effectiveness of medicines, the first to involve both medical and veterinary sectors. The theme of this inaugural Summit, “phasing out over-the-counter (OTC) sales of antibiotics”, was chosen based on pre-Summit consultations and research that identify non-prescription medicines as a major driver of improper use of antibiotics. A 2019 systematic review and meta-analysis evaluated 38 studies that assessed the prevalence of obtaining antibiotics without prescription and reported an overall pooled estimate of 62% (95% CI 53–72), despite 23 of the 24 study countries having regulations against such practice. In the animal sector there are similarly high rates of OTC sales, but antibiotics are not exclusively used for disease treatment, instead most OTC antibiotics are administered at low doses for the sole purpose of increasing livestock growth and, according to the World Organisation for Animal Health, half of countries that use OTC antibiotics for growth promotion actually have regulation against it. The presentation of these data resulted in the first theme to emerge from the Summit: an AMR legislative framework exists but is difficult to enforce. Although enforcing AMR legislation is difficult, some countries presented their success. Amber McCoig (US Food and Drug Administration, Rockville, MD, USA) showed how the USA phased out all OTC sales of animal antimicrobials, a 20-year process that involved close collaboration with veterinarians and farmers and an extensive media campaign. Similarly, Franck Fourès (ANSES, Javené, France) described how France implemented a so-called pyramid of traceability that tracks the antibiotic from its production at the pharmaceutical plant to purchase by a livestock farmer—the planning and implementation of which has spanned the past 50 years. Both the USA and the majority of Europe have phased out using antibiotics for livestock growth promotion. Such long-term, sustained efforts are commendable, but might not be replicable in other countries, particularly in low-income and middle-income countries (LMICs) that have different priorities and challenges in regulating antibiotics. Sabrina Yesmin, Directorate General of Drug Administration at the Bangladeshi Ministry of Health (Dhaka, Bangladesh) told The Lancet Microbe: “In Bangladesh, 22·7% of antibiotics are being sold without prescription, it is a big problem.” To find out what drove these OTC sales in Bangladesh, the Ministry of Health conducted a baseline survey of 427 pharmacists; “According to this survey”, said Yesmin, “67% of the drug sellers could not correctly identify the antimicrobial drug; we found a huge lacking in their education and, in our country, AMR issues are not included in pharmacy courses”. The Bangladeshi government is working to improve antibiotic distribution, both in the human and animal sector, by educating pharmacists and the public on AMR through advocacy workshops and media campaigns and applying red labels to priority antibiotics that can be easily identified by the prescribing practitioner. AMR advocacy and stewardship is crucial to ensuring proper use of antibiotics but, for a lot of people, quickly obtaining medicine is a priority over responsibly obtaining medicine. Establishing the social determinants of antibiotic use in people was the second theme that emerged throughout the 2-day Summit. Moji Adeyeye, Director–General of the National Agency for Food & Drug Administration and Control (NAFDAC; Abuja, Nigeria) presented that, in Nigeria, getting antibiotics can be a “matter of life or death” and ending poverty will affect how people view antibiotics. When asked about what needs to be done to improve antibiotic seeking behaviour Adeyeye told The Lancet Microbe that the extent of the problem is unknown due to data gaps: “For LMICs, it is extremely important for academia and regulators to collaborate…we [drug regulators] do not have the data to drive regulatory policy”. Adeyeye urged the Quadripartite to set up partnerships with LMIC universities and research institutions to facilitate research, particularly on the prevalence of illegal selling of substandard (ie, authorised medicines that have failed to meet quality standards or have expired) or falsified (ie, unauthorised products that are fraudulently represented as effective medicine) medicines in LMICs. According to WHO, one in 10 medical products in LMICs is substandard or falsified, of which antibiotics accounted for 17% of falsified products. However, conducting such research is difficult as selling of these ineffective medicines usually happens within black markets. Zivani Makoni (Medicines Control Authority of Zimbabwe, Harare, Zimbabwe) presented on the practice of selling counterfeit medicines in street markets in Zimbabwe, with veterinary products (particularly water-soluble antibiotics for poultry, cattle dewormers, and livestock dipping chemicals) being the most prevalent. Regulation of this black market is difficult and currently relies on the prosecution of sellers but according to the accompanying paper by the Medicines Control Authority of Zimbabwe: “Despite the availability of legislation and standards, there appears to be a general perception that the risk of prosecution is very low“. Makoni described how the Medicines Control Authority is trialling handheld spectrometer devices that scan drugs entering the country and detect unexpected ingredients; however, he emphasised that improving access to affordable medicine is the key to reducing the number of substandard and falsified medicines that are sold. In Zimbabwe, access to health care is dependent on health insurance, which is mostly tied to employment, and only 11% of women and 12% of men are estimated to have health insurance in the country. Such economic challenges, said Makoni, are causing the general population to evade doctor or veterinarian consultation fees and seek cheaper options. In Indonesia, a network of criminals targeted the proportion of the poulation who could afford to pay for health care and were profiting off middle-class parents who were willing to pay for their child's vaccinations. The network operated for more than a decade selling falsified vaccines that contained saline and suboptimal doses of antibiotics to health centres, with the Indonesian Ministry of Health reporting that 5000 children received falsified vaccines in 2016 alone. No children were reported to have been harmed by the ingredients in the falsified vaccine but they will not have been protected against the diseases supposedly targeted by the vaccine and the low dose of antibiotics will likely have facilitated the spread of AMR genes in the environment. The examples from Zimbabwe and Indonesia show that controlling the selling of substandard or falsified medicines is deeply rooted in the socioeconomics of the country and that qualitative information on local class systems and health-seeking behaviour is valuable in informing AMR policy. A qualitative study on the social determinants of antibiotic use that was praised by academics and government officials during the Summit was the findings of the ABACUS project published in The Lancet Global Health in 2021. The study was commended for its mixed methods approach to assessing antibiotic access in six LMICs across Africa (Mozambique, Ghana, and South Africa) and Asia (Bangladesh, Vietnam, and Thailand) that included 8214 exit interviews with customers who had just purchased antibiotics, of whom 2875 (35%) had obtained antibiotics without prescription. Conducting exit interviews is an effective but labour-intensive method of collecting information on health-seeking behaviour. However, it does not capture a widespread issue that emerged as the final theme of the Summit: internet sales of antibiotics are a major global problem. Purchasing antibiotics via legal or illegal websites is prevalent in both the human and animal sectors and, due to the ease of international shipping, is a problem that affects all countries, regardless of income level. In an investigation of 261 websites selling antibiotics for use in animals, the majority (n=153 [59%]) did not require a veterinary prescription. A similar study of 20 online sellers of human antibiotics accessible from the UK showed that most (n=16 [80%]) did not require prescription, with the antibiotic type, dose, and quantity all being decided by the consumer. Alla Samoylova (Federal Service for Surveillance in Healthcare, Moscow, Russia) presented Russia's approach to addressing this problem that involved state monitoring of internet searches, which led to the blocking of over 45 000 websites that were suspected to be offering non-prescription antibiotics. Despite many countries voicing that internet sales were prevalent, Russia was the only country to present on how to control this issue and this approach is unlikely to be replicated by countries with regulations against mass surveillance and censorship. It was clear that antibiotic seeking behaviour and regulation differed between countries. Although the first iteration of this Summit presented more challenges than solutions to mitigating AMR, it was an opportunity for countries to share their varied expriences. The success stories that were shared involved a multidisciplinary effort that spanned several years or decades and the Quadripartite recognises that the Summit will need the same long-term commitment. In the closing remarks, Haileyesus Getahun, Director of AMR Global Coordination at WHO and the Quadripartite urged the drug regulators to actively participate in inter-Summit conversations and continue to consider both humans and animals when developing AMR policy. Participants of the Summit were invited to submit questions or comments as part of the closing remarks in which one anonymous participant voiced that, in order for LMICs to be involved in future conversations, the Summit should not be held in Geneva but rather a location that is accessible and visa-friendly to these countries. The next AMR Summit is planned for 2025, the theme and location are yet to be decided.